Catheter-based management of valvular heart disease: from TAVI to Mitraclip, Cardioband, and tricuspid interventions

For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts. The treatment of valvular heart disease was traditionally the domain of cardiac surgeons. However, during the last decade, catheter-based valve interventions starting with transarterial aortic valve implantation (TAVI), then Mitraclip, and more recently percutaneous mitral valve replacement and experimental tricuspid valve procedures became increasingly important in this patient population. The most recent developments are summarized in ‘The Year in Cardiology 2018: valvular heart disease’ by Wojciech Wojakowski et al. from the Silesian School of Medicine in Katowice, Poland.1 In 2018, publications on valvular heart disease addressed epidemiology, diagnosis, therapy, and predictors of outcome, but were dominated by studies on transcatheter treatment. Most importantly, two pivotal studies investigated the Mitraclip in secondary mitral regurgitation and divergent results were published2,3 that are discussed in depth. In aortic stenosis, there is a trend towards the expansion of indications for TAVI to intermediate and low-risk groups, to bicuspid aortic valves and failed surgically implanted bioprostheses. Tricuspid edge-to-edge interventions are being investigated4,5 as isolated tricuspid valve surgery has a high risk and is currently rarely performed. The future of these interventions is further discussed in the review ‘Transcatheter heart valve interventions: where are we? Where are we going?’ by Jeroen J. Bax et al. from Leiden University Medical Center in Leiden, The Netherlands.6 The authors remind us that technological advances extended TAVI to younger or lower risk patients and those with other forms of valvular heart disease such as tricuspid and mitral regurgitation. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of TAVI in these groups. Thus, all stakeholders should collaborate to evaluate these broader indications for TAVI. It is essential to address (i) device durability and deliverability; (ii) specific anatomical characteristics (e.g. bicuspid aortic valves, aortic, mitral, or tricuspid regurgitation); (iii) operator training; and (iv) the reinforced importance of the multidisciplinary HeartTeam. In a Fast Track clinical research article entitled ‘Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification’, Raj Makkar and colleagues from Cedars-Sinai Heart Institute in Los Angeles, California sought to evaluate in 521 patients with a mean STS score of 9.0 ± 7.0% the outcomes of transcatheter mitral valve replacement in degenerated bioprostheses (valve-in-valve), failed annuloplasty rings (valve-in-ring), and severe mitral annular calcification (valve-in-mitral valve calcification).7 Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after valve-in-mitral valve calcification compared with valve-in-ring and valve-in-valve. Second valve implantation was more frequent in valve-in-ring compared with valve-in-mitral valve calcification and valve-in-ring. Accordingly, technical success rate was the highest in the valve-in-valve group, followed by valve-in-ring and valve-in-mitral valve calcification groups. However, valve-in-ring had more frequent post-procedural mitral regurgitation of moderate degree or more and subsequent paravalvular leak closure. The 1-year all-cause mortality was significantly higher in the valve-in-mitral valve calcification compared with the two other groups (Figure 1). On multivariable analysis, the type of procedure (valve-in-ring vs. valve-in-valve, hazard ratio 1.99; valve-in-mitral valve calcification vs. valve-in-valve, hazard ratio, 5.29) and post-procedural mitral regurgitation of moderate or severe degree with a hazard ratio of 1.72 were associated with mortality. Thus, transcatheter mitral valve replacement for degenerated bioprostheses provided excellent outcomes in high-risk patients. However, valve-in-ring and valve-in-mitral valve calcification were associated with higher rates of adverse events and mid-term mortality compared with valve-in-valve. This important experience with these novel interventions is put into context in an interesting Editorial by Francesco Maisano and Maurizio Taramasso from the University Hospital in Zurich, Switzerland.8 The cumulative all-cause mortality rates with landmark analyses (0-30 days and 30-360 days) showed increased early mortality (0-30 days) but also late mortality (30-360 days) after valve-in-MAC compared with valve-in-ring and valve-in-valve. MAC, mitral annular calcification (from Yoon S-H, Whisenant BK, Bleiziffer S, Delgado V, Dhoble A, Schofer N, Eschenbach L, Bansal E, Murdoch DJ, Ancona M, Schmidt T, Yzeiraj E, Vincent F, Niikura H, Kim W-K, Asami M, Unbehaun A, Hirji S, Fujita B, Silaschi M, Tang GHL, Kuwata S, Wong SC, Frangieh AH, Barker CM, Davies JE, Lauten A, Deuschl F, Nombela-Franco L, Rampat R, Nicz PFG, Masson J-B, Wijeysundera HC, Sievert H, Blackman DJ, Gutierrez-Ibanes E, Sugiyama D, Chakravarty T, Hildick-Smith D, de Brito Jr FS, Jensen C, Jung C, Smalling RW, Arnold M, Redwood S, Kasel AM, Maisano F, Treede H, Ensminger SM, Kar S, Kaneko T, Pilgrim T, Sorajja P, Belle EV, Prendergast BD, Bapat V, Modine T, Schofer J, Frerker C, Kempfert J, Attizzani GF, Latib A, Schaefer U, Webb JG, Bax JJ, Makkar RR. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification. See pages 441--451). In their FAST TRACK article ‘Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration’ Ronak Delewi and colleagues from the Academical Medical Centre in Amsterdam, The Netherlands compared outcomes of patients with a Euroscore of 15% undergoing transfemoral TAVI with balloon-expandable valves vs. self-expandable valves from 10 registries and trials.9 The population included 6239 undergoing TAVI with balloon-expandable valves and 6142 patients with self-expandable valves. At 30-day follow-up, mortality rates were not statistically different in patients between the two groups (Figure 2). However, stroke occurred more frequently in those with self-expandable valves. Also, they had a 2.5-fold higher risk of pacemaker implantation, whereas those treated with balloon-expandable valves more frequently experienced major and life-threatening bleedings. Thus, with similar mortality with both valve types, stroke and pacemaker implantation occurred more frequently with self-expandable valves, while major bleedings were more common with balloon-expandable valves. Mortality at 30 days was not statistically different in patients treated with self-expandable valves compared with balloon-expandable valves. The current study was a propensity-matched analysis generated from observational data; accordingly, current outcomes will have to be confirmed in a large-scale randomized controlled trial. Clinical outcomes in patients treated with early-generation balloon-expandable valves compared with early-generation self-expandable valves, and new-generation balloon-expandable valves compared with new-generation self-expandable valves (from Vlastra W, Chandrasekhar J, Muñoz-Garcia AJ, Tchétché D, de Brito Jr FS, Barbanti M, Kornowski R, Latib A, D Onofrio A, Ribichini F, Baan J, Tijssen JGP, Trillo-Nouche R, Dumonteil N, Abizaid A, Sartori S, D’ Errigo P, Tarantini G, Lunardi M, Orvin K, Pagnesi M, del Valle R, Modine T, Dangas G, Mehran R, Piek JJ, Delewi R. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration. See pages 456--465). In spite of its prognostic importance10 and the availability of specific risk scores,11 mitral regurgitation is still not fully recognized by currently practising physicians.12 While Mitraclip treats insufficient leaflet coaptation,13 it does not—unlike surgery—reduce the enlarged mitral anulus. The Cardioband™14,15 is a novel transcatheter implant designed to reduce mitral annulus size and mitral regurgitation severity which is still under evaluation.16 In their article ‘Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1-year outcomes’, David Messika-Zeitoun and colleagues from the University of Ottawa Heart Institute in Ontario, Canada report the 1-year outcomes of 60 consecutive patients who underwent the procedure.17 There were two in-hospital deaths (none device related), one stroke, two coronary artery complications, and one tamponade. Anchor detachment, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in 5 patients and led to device modification half way through the study. Technical, device, and procedural successes were 97, 72, and 68%, respectively. One-year survival, and survival free of readmission for heart failure or free of re-intervention were 87, 66, and 78%, respectively. Overall, mitral regurgitation at 12 months was moderate or less in 61%. Functional status, quality of life, and exercise capacity all improved. Thus, the Cardioband system demonstrated reasonable feasibility and safety. These initial findings are further discussed in an Editorial by Yaron Shapira from the Rabin Medical Center at Beilinson Hospital in Petah-Tiqva, Israel.18 Tricuspid regurgitation has a dismal outcome19,20 and—as recently discussed21,22—its management remains uncertain. In their Meta-analyis entitled ‘Tricuspid regurgitation is associated with increased mortality independent of pulmonary pressures and right heart failure: a systemic review and meta-analysis’, Nelson Wang et al. from the University of Sydney in Australia evaluated the influence of tricuspid regurgitation severity on mortality.23 Overall, 32 601 patients followed up over 3 years were analysed. Moderate or severe tricuspid regurgitation was associated with a two-fold increased total and cardiac mortality. This remained significant when adjusted for systolic pulmonary arterial pressures or right ventricular dysfunction. Moderate/severe tricuspid regurgitation was also associated with increased heart failure hospitalization. Compared with patients with no tricuspid regurgitation, patients with mild, moderate, and severe tricuspid regurgitation had a progressively increased risk of all-cause mortality, with hazard ratios of 1.25, 1.61, and 3.44, respectively. These findings are put into context in an Editorial by Maurizio Taramasso from the University Hospital in Zürich.24 This issue is complemented by various Discussion Forums and the authors respond in their own contribution. In their contribution entitled ‘Acute haemolysis after transcatheter mitral valve implantation’ Julien Ternacle et al. from the Henri Mondor Hospital in Creteil, France comment on the recently published paper ‘Clinical and haemodynamic outcomes of balloon-expandable transcatheter mitral valve implantation: a 7-year experience’ by Dominique Himbert and colleagues from the Bichat Hospital in Paris, France.25,26 In another contribution ‘Outcome after transvascular transcatheter aortic valve implantation in 2016: a closer look’ Armin Welz et al. from the Universitatsklinikum Bonn in Germany discuss the recently published paper ‘Outcome after transvascular transcatheter aortic valve implantation in 2016’ by Helge Möllmann and colleagues from the St. Johannes Hospital in Dortmund, Germany.27,28 The editors hope that this issue of the European Heart Journal will be of interest to its readers. With thanks to Amelia Meier-Batschelet for help with compilation of this article.